510(k) K081867 ยท HAW Neurological Stereotaxic Instrument
MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0
| Applicant | Mako Surgical Corp., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Nov 25, 2008 |
| Received | Jul 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081867
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2012 | Mako Surgical Corporation The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000).
The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anat Terminated |
OLO | None listed |
| Oct 19, 2009 | Mako Surgical Corporation 200996-Cable Assembly, Hybrid Extended Length,
200997 Cable Assembly, Hybrid, Guidance Module,
200998 Cable Assembly, Hybrid, UI Panel
Subcomponents for the 203000 RIO STANDARD SYSTEM
Manufactured Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.